Almost two years have passed since Mercy Hospital temporarily paused all nonemergent or elective surgeries after identifying a “potential process gap in cleaning some surgical trays and instruments.”
At the time, then-CEO Patrick Sharp said, “We are not aware of any infections (to patients) caused by this potential processing gap.”
Two patients filed a lawsuit against the hospital Dec. 20, alleging they contracted postoperative infections about the time Mercy paused elective surgeries for sterilization issues. They allege negligent behavior on the part of the hospital, which is owned by Centura Health Corp. The lawsuit, filed in 6th Judicial District Court in La Plata County, seeks an unspecified dollar amount in damages for the plaintiffs’ medical expenses, physical impairment, and pain and suffering.
Dr. Douglas Orndorff, the orthopedic spine surgeon who conducted both surgeries, said in an interview this week with The Durango Herald that a total of three patients (the lawsuit claims the number was five) developed postoperative infections around that time.
Orndorff works for Spine Colorado, a practice independent of Mercy Hospital. Although he does not work for the hospital, he has served as the chairman of Mercy’s surgery department since 2014. He is not named as a defendant in the lawsuit.
The plaintiffs, David Huhn of Mancos and Cheryl Esgar of Ignacio, both had back surgery at Mercy in December 2020 and January 2021, respectively.
On Feb. 3, 2021, nearly six weeks after his surgery, Huhn was readmitted to the hospital after he experienced difficulty walking and “was having cognition issues, his breathing rate was slow, shallow, and labored, and he was slurring his speech,” according to the complaint.
Esgar first experienced immense pain around her surgical site more than two weeks after her surgery and around the same time Huhn was readmitted to the hospital.
Orndorff ultimately concluded that both patients had abscesses in or around their spines, and both required follow-up surgeries.
The hospital paused all elective procedures Feb. 19.
Sharp announced a “process gap” in the Sterile Processing Department when he broke news of the decision to pause surgeries February 2021.
In July 2021, the Colorado Department of Public Health and Environment cited the hospital for failing to ensure hospital staff members followed manufacturers' instructions when sterilizing instruments.
According to the lawsuit and findings of an investigation by CDPHE, problems in the SPD stemmed from incorrect data in Surgio, the software Mercy uses in its sterilization process.
Surgio allows SPD technicians to catalog specific instructions for individual surgical instruments that dictate how long the instruments must soak in a cleaning solution and how long they need to spend in the autoclave, an appliance that sterilizes instruments with heat and pressure.
The investigation conducted by CDPHE in July 2021 found numerous discrepancies between the soaking and sterilization times maintained by the SPD in Surgio and those required by the tools’ manufacturers.
In one case, the department’s practice said to soak a specialized group of instruments for five minutes and expose them to the autoclave for four minutes. The manufacturer of those instruments required a 15-minute soak time and an eight-minute exposure.
The CDPHE citation said the interim director of surgery, who was not named, told investigators that all information in Surgio was entered manually by the department’s staff members, according to manufacturers’ recommendations.
When the hospital paused surgeries, Sharp said in a statement the hospital was unaware of any infections resulting from the so-called processing gap. But Orndorff said the decision to pause surgeries only came after several patients developed postoperative infections.
According to the surgeon, his antennae first went up when three of his patients developed postoperative infections within a few weeks of one another. That was highly unusual, Orndorff said. It prompted his colleagues and him to approach Mercy in mid-February and suggest halting surgery until a cause could be determined. He said the hospital took the request seriously.
“I was the loudest advocate to say, ‘We’ve got to figure out what’s going on,’” he said. “Clearly something (was) going on, whether it’s coincidence – and it could have been – or whether it’s a process. We definitely were, as the surgeons and the anesthesiologists, the advocates to say, ‘We got to figure this out.’ Mercy heard that, and then Mercy responded by supporting the pause until we figured out what was going on. I think it was collaborative.”
The hospital did a “significant deep dive,” Orndorff said, into its sterile processing procedures, which led SPD staff to conclude that it was not a singular shortfall that could be responsible for the infections. It would be unlikely for reduced autoclave exposure time alone to lead to complications.
Orndorff said this is the nature of modern medicine – and as a surgeon, he is comfortable with the improved transparency and checks and balances that resulted from the “deep dive.”
The SPD made many changes after investigating its own practices, which included the purchase of a new ultrasonic cleaner, rectifying the time discrepancies in Surgio and installing a larger sink.
The CDPHE inspection, which took place throughout July 2021, found numerous gaps in SPD procedures still existed. It is unclear when surgeries resumed after they were paused Feb. 19. A follow-up inspection Aug. 25 found that all procedures were in compliance with regulations.
Centura Health did not respond to requests for comment for this story.
“They definitely have clearly made big strides to tighten the ship,” Orndorff said, emphasizing the hospital’s willingness to work with staff members to improve conditions.
While Orndorff appears to be content with the way the hospital handled the procedural issues, the patients suing the hospital are not.
In addition to the claims of negligence alleging the hospital breached its duty to patients by failing to ensure that proper sterilization techniques were used, the plaintiffs claim Mercy engaged in “extreme and outrageous conduct.”
The basis of the claim is not only the mistakes in the SPD department, but the lack of communication to the patients about the problem.
According to the complaint, Esgar was scheduled for follow-up surgery on Feb. 19 – the day the hospital paused nonemergent and elective procedures. When doctors postponed her surgery, they told her the delay was “to see how she responded to ongoing intravenous antibiotics.”
Esgar underwent a second surgery on Feb. 22 to address the infection. The lawsuit alleges that her condition had become critical by that date, meaning the surgery was no longer “elective,” and could proceed despite the pause.
Neither Esgar nor Huhn were told about the decision to pause surgeries, according to the lawsuit. Both patients found out by reading a March 4 story in The Durango Herald.
The plaintiffs’ attorney declined to make his clients available for comment.
Centura Health has not yet filed a response to the lawsuit.
rschafir@durangoherald.com
This story has been updated to clarify that the Surgio software maintains a catalog of sterilization parameter information entered by hospital staff. It does not provide sterilization information itself.
